A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in...

Area of Science:

• Clinical research methodology
• Health informatics

Background:

• The adoption of electronic patient-reported outcome (ePRO) data collection via bring your own device (BYOD) is increasing in clinical trials.
• A preliminary evaluation was conducted to assess ePRO using BYOD for regulatory-required observational post-marketing surveillance (PMS) in Japan.

Purpose of the Study:

• To evaluate the processes and feasibility of implementing ePRO using BYOD for post-marketing surveillance in Japan.
• To compare data completeness and usability of ePRO with traditional paper-based PRO methods.

Main Methods:

• A multicenter, two-period, two-sequence, cross-over observational study was performed.
• Participants were divided into two groups, one starting with ePRO and the other with paper PRO, for seven days each.
• Usability, implementation, support, and materials for ePRO were assessed via questionnaires.

Main Results:

• Data collection with ePRO was comparable to paper PRO, with no significant differences in data entry status based on sex or age-related missing data trends.
• Over half of participants responded favorably to ePRO system questionnaires.
• Investigators found ePRO system materials useful, but identified areas for improvement.

Conclusions:

• ePRO demonstrated comparable data completeness to paper methods in motivated clinical settings during a two-week pilot.
• Key considerations for implementing ePRO in actual PMS were identified.
• Further evaluation in studies compliant with local regulations is recommended.